By Shalini Bhardwaj

New Delhi [India], December 31 (ANI): The Government of India has banned the manufacture, sale and distribution of oral formulations of the painkiller nimesulide containing more than 100 mg in immediate-release dosage form.

The ban does not apply to oral formulations below 100 mg, higher strengths in sustained or extended-release forms, or non-oral formulations such as topical gels, creams, and suppositories, a statement from the Ministry of Health and Family Welfare said.

The decision was taken following a review by the Indian Council of Medical Research (ICMR), the country's apex health research body. The government said that higher-dose oral formulations of nimesulide pose potential risks to human health and that safer alternatives are available.

In a notification, the government said, 'The Central Government is satisfied that the use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form is likely to involve risk to human beings and that safer alternatives to the said drug are available.'

The notification further read, 'The Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the said drug in the country for human use.'

Citing its legal authority, the government notification added, 'Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), and after consultation with the Drugs Technical Advisory Board, the Central Government, hereby prohibits the manufacture, sale and distribution of the following drug, with immediate effect.'

The notification specifically listed, 'All oral formulations containing Nimesulide above 100 mg in immediate-release dosage form.'

Medical experts have welcomed the move Dr S Chatterjee, Senior Consultant in Internal Medicine at Apollo Hospitals, said the ban was long overdue, noting that the drug had already been restricted in several countries.

'Nimesulide was banned much earlier in quite a few countries. To ban Nimesulide by the government is a welcome decision because it was being used rampantly and injudiciously to treat high-grade fever without realising the potential side effects of liver injury/damage. Also, kidney injury and gastritis,' he said. (ANI)